DESCRIPTION: Elysium has discovered a novel molecular deactivation (XpiRx or expiring pill) technology that is designed to effectively curb the widespread abuse and diversion of unused prescription opioid drugs. Using Elysium's technology, opioid drug products will safely, and irreversibly lose their potency over a specified time window beyond the prescribed use period, rendering them devoid of opioid agonist effects, and, therefore, completely abuse-resistant. Our XpiRx technology enables: (i) effective pain relief during the prescribed use period; (ii) abuse-resistance via non-oral routes; (iii) oral abuse-deterrence beyond the prescribed use period; and (iv) oral overdose protection beyond the programmed expiration date. According to President Obama, Prescription drug abuse is America's fastest-growing drug problem, and one largely fed by an unlikely source - Americans' medicine cabinets. Over 70% of abusers obtain unused prescription opioids from their friends and family. Current opioid pills lose only ~1% of their potency per year, resulting in a 70-year potency half-life. Elysium's XpiRx technology dramatically shortens the opioid drug's potency half-life, which would substantially decrease the pool of drugs (diversion pool) that attract abusers. We are applying for Fast-Track because NIDA program officials assured us that our proposed project is an excellent Fast-Track candidate based on: Compelling in vitro data from studies led by our Principal Investigator coupled with published Phase 1 human data demonstrate the feasibility of achieving unprecedented abuse- and diversion-resistance with XpiRx technology; The lack of technologies in development or on the market that address diversion, the primary source for abused prescription opioid drugs; and Key stakeholder interest: The Office for National Drug Control Policy (ONDCP) and The National Institute on Drug Abuse (NIDA) have identified diversion as a high priority issue because it fuels the prescription drug abuse epidemic. Pharmaceutical company leaders believe that XpiRx could become a standard safety requirement for opioid drugs (like airbags for automobiles).